NORTHERN ILLINOIS COUNSELING ASSOCIATES, P.C. (NICA)

NICA OPIOID RISK ASSESSMENT (NORA)

A TREATMENT PROTOCOL FOR ASSESSING AND MANAGING PAIN

BASED ON PATIENT'S RISK OF OPIOID MISUSE, ABUSE, AND/OR ADDICTION,

AND METHOD OF USE

THEORETICAL, RESEARCH, AND CLINICAL PRACTICE RATIONALE

Purpose

This instrument provides for a professionally-administered, face-to-face, structured clinical interview, specific to the assessment of exclusionary and/or cautionary psychobiosocial risk factors, informed by competent clinical judgement, with the option to obtain concomitant corroborating qualitative and/or quantitative information and/or records (i.e., medical, legal, employment, correctional, military, etc.) associated with the healthcare consideration of opioid therapy (inclusive of prescription, titration, use, abuse, withdrawal, etc.) and, further, clinically substantiated with a professionally-administered, face-to-face, structured clinical interview, specific to the assessment of possible Opioid Use Disorder, consonant with the diagnostic criteria specified in the DSM-5 (or subsequent versions), with the express written permission by the American Psychiatric Association for adapted use by Northern Illinois Counseling Associates, P.C. (NICA).

Brief Background

The NORA is a compilation of more than forty (40) years, respectively, of each of the authors education, training and experience in the profession of clinical psychology with thousands of patients, of widely varying mental health, and also medical health, related diagnoses, inclusive of drug addiction (of which Opioid Use Disorder, more specifically, is subsumed).

The NORA is a proprietary assessment and evaluation due-diligence-methodology whose manifest purpose is to systematize, standardize and summarize self-report information and relevant personal data about a given patient to render a psychobiosocial risk assessment and evaluation of actual, suspected or unexpected DSM-5-based (or subsequent DSM) diagnosis of an Opioid Use Disorder, as well as, to make recommendations for further disposition, to anticipate, to address and/or to mitigate suspected, probable or actual risk, if applicable.

The World Health Organization (WHO) (www.who.int) defines its central mission as improving well-being which is defined as an overall state of health and happiness at the psychological, biological and social levels. Therefore, a structured, clinical, face-to-face assessment of psychobiosocial risk factors in a given patient for whom opioid therapy may be an issue, as well as, clinical evaluation of the presence or absence of an extant DSM-5 based (or subsequent DSM-based) diagnosis of Opioid Use Disorder is clearly of paramount importance to the mission of WHO in improving well-being, per above.

Objectives of the NORA

Creation of the NORA has been specially designed to accomplish three (3) main objectives:

The NORA will save lives by carefully assessing psychobiosocial risk factors in patients for whom opioids are being considered, used, titrated or withdrawn and in evaluating whether or not an Opioid Use Disorder is diagnostically warranted in accordance with the DSM-5- (or subsequent DSM versions) based criteria for which specific recommendations may be made for appropriate treatment or for the inclusion of other appropriate healthcare services.

The NORA will mitigate liability to prescribers, their agencies and payors by providing a systematic methodology for assessing a wide spectrum of psychobiosocial risk factors associated with opioid therapy in a given patient and also for evaluating whether or not a demonstrable DSM-5- (or subsequent DSM versions) based criteria for a diagnosis of Opioid Use Disorder exists in the patient for which clinically relevant and appropriate treatments and/or other healthcare services may be recommended and/or implemented given available resources.

The NORA will conserve money with respect to aggregate healthcare cost offset, across-the-board (inclusive of the ‘system-at-large’ resources), by systematically focusing upon a multitude of psychobiosocial risk factors and upon the American Psychiatric Association’s DSM-5- (or subsequent DSM versions) based criteria diagnostic criteria to carefully screen new patients for whom opioid therapy is being considered by their prescriber and/or to monitor existing patients for whom opioid have been prescribed, as an intentional precursor to opioid prescription (inclusive of titration, withdrawal, etc.)

Problem

Patients who are prescribed opioid therapy are, typically, not systematically assessed by their prescribers for various exclusionary and/or cautionary psychobiosocial risk factors which may increase or decrease ‘risk’ of opioid use nor are such patients, typically, evaluated for an Opioid Use Disorder in accordance with the diagnostic criteria specified in the DSM-5 (or later versions) nor are psychobiosocial risk factors addressed specific to risk-mitigation.

Solution

The NICA OPIOID RISK ASSESSMENT (NORA) protocol includes the NICA PSYCHOBIOSOCIAL RISK ASSESSMENT: DIAGNOSTIC INTERVIEW and the NICA OPIOID USE DISORDERS RISK ASSESSMENT: DSM-5-BASED CRITERIA and is a structured, face-to-face, clinical interview specifically designed to be administered by those duly-licensed healthcare professionals who are legally authorized (with the requisite training, credentialing, experience and clinical judgement), to adequately render a DSM-5-based (or subsequent DSM) diagnosis of an Opioid Use Disorder (OUD).

The protocol is to be administered in its entirety and, when completed, represents a significant psychobiosocial foundation upon which an assessment of psychobiosocial risk and an assessment of DSM-5-based opioid-related diagnosis may be made.

Additionally, the entire protocol is the report, in toto, of the NICA OPIOID RISK ASSESSMENT (NORA) and serves as an organic document to facilitate meaningful clinical inquiry, continuing dialogue and appropriate dispositional planning and/or treatment implementation with the Patient about the multiple life-domain stressors associated with their potential or actual opioid use, abuse, dependency, tolerance, withdrawal, and/or additional healthcare consideration of salient risk factors which may positively or negatively impact consideration of opioid therapy.

The NORA concludes with a brief NORA ASSESSOR SUMMARY REPORT which has been, especially, structured to enable the Assessor to rapidly summarize both the NICA PSYCHOBIOSOCIAL RISK ASSESSMENT: DIAGNOSTIC INTERVIEW, as well as, the NICA OPIOID USE DISORDERS RISK ASSESSMENT: DSM-5-BASED CRITERIA sections of the NORA and to provide a cumulative RISK FACTOR SEVERITY QUARTILE rating. The two (2) page NORA Assessor Summary Report may be utilized as an abbreviated health care, stand-alone, record if there is need to protect the "raw data" health information of the patient from requestors of the NORA.

The NICA OPIOID RISK ASSESSMENT (NORA) is an ethical, efficient, effective and cost-effective method to assess psychobiosocial ‘risk’ and to evaluate the presence or non-presence of an Opioid Use Disorder in a patient for whom opioid therapy is at issue and can be administered in approximately 60 minutes or so.

Benefits

An invaluable benefit of the NORA is for the Assessor to render an informed clinical judgement, either implicitly or explicitly, to the referring entity concerning the ‘decisional capacity’ of a given patient, with respect to the patient’s readiness, willingness and ability to meaningfully understand, process and utilize relevant and/or complex information about their current and/or long-term healthcare status and associated treatment recommendations, in order for the patient to make intelligent and reasoned choices consonant with their personal, cultural and normative values and to provide requisite informed consents to expressly authorize further healthcare disposition, whenever possible.

Foundation of the NORA

The NORA has been informed by existing theory, research and practice in psychology and medicine, as well as, distillation and application of knowledge about psychobiosocial risk factors and diagnostic criteria specific to opioid use (and other substance use and/or comorbid mental and/or medical health) disorders gleaned from direct patient-contact by the authors, both clinical psychologists, for more than forty (40) years, respectively.

The abstract ‘idea’ about what constitutes relevant psychobiosocial risk factors emanates from both, a priori and a posteriori, clinical assumptions, necessarily, correlates with patient self-report (and other sources of corroborating collateral, psychological, medical, legal, military, employment, etc.) information leading to considered clinical judgements as to the nature, severity, frequency, duration, amplitude and latency of assessed risk factors in provisionally hypothesizing whether or not the risk of opioid therapy is greater than the benefit, all things considered.

This ‘clinical judgement’ is, additionally, informed by careful and appropriate utilization of the DSM-5-based (or subsequent DSM) criteria, specific to Opioid Use Disorder, in deciding whether or not the patient meets the diagnostic criteria for an Opioid Use Disorder.

Admittedly, the construct of ‘risk’ and what constitutes ‘risk’ requires a modicum of “common-sense” coupled with the due-diligence of informed professional ‘clinical judgement’.

For example, if an individual has a highly infectious disease, it is, generally, ill-advised for them to participate in communal activities which might, unintentionally, infect others.

Or if a person is suffering from an open wound on their hand, it is probably not a good idea for them to bake cookies for a group of young children.

The point is that ‘risk’ will be fairly clear to identify, as exclusionary, for most observers as the more blatant, flagrant and obvious the risk, the greater will be the likelihood of that ‘risk.’

However, what may be less clear is when risk is not apparent (viz., the captain of the Titanic inquiring of his lookout if he saw any danger and the lookout, speculatively, replied “all is well”) in which case the astute observer must be vigilant to consider less obvious, cautionary, risk factors.

The NORA intentionally does not presume to specify ‘exclusionary’ or ‘cautionary’ psychobiosocial risk factors to allow for, and to respect, the requisite clinical judgements of local Assessors and local Prescribers, to define such terms in accordance with their usual and customary community and/or professional practice standards and/or ethical aspirations of healthcare.

Moreover, the NORA intentionally does not presume to specify what Recommended Concurrent Services are to identified, if applicable, since NORA guidance to Prescribers, for all intents and purposes, is suggestive and not prescriptive and is based upon clinical consideration of exclusionary and/or cautionary psychobiosocial risk factors, endemic to the NORA protocol, which must not be used as the sole source or as the sole determining consideration regarding the Patient’s medical suitability for opioid therapy or as the sole source or as the sole determining consideration for medically denying opioid therapy, especially, since it is the authors’ professional opinion that medical decisions about, primarily, medical procedures, are the appropriate purview of medical practitioners.

The construct of ‘risk’ is to be viewed, herein, simultaneously as both an abstract idea and as a concrete datum.

As an abstract idea, risk can be virtually anything in the known or unknown universe of actual and/or imagined possibilities which may, or may not, represent a necessary and/or contributory condition, or ‘risk factor’ to aid, hinder or threaten a given individual (or others).

One example might be construing the human body as “nature’s best pharmacy” and declining opioid prescription for a person who complains of severe pain because of the Prescriber’s belief in the healing powers of nature taking its course.

While the human body may be “nature’s best pharmacy”, and while health is both an abstract idea, as well as, a concrete datum, the purpose of a healthcare professional is to do something to lend an assist to nature taking its course.

As a concrete datum, risk can be anything which by dint of experience, education, training, supervision or vicarious learning, one simply knows that an actual or potential risk exist for which “an ounce of protection is worth a pound of cure” (e.g., the intentional mitigation of risk of an infectious disease with recourse to vaccinations to provide inoculation from the worst of the anticipated threat, danger or harm).

Consequently, the NORA serves to assess suspected, probable, possible and/or actual psychobiosocial risk factors for a given patient, for whom opioid therapy is being considered or has been prescribed, in service of the goal: “to be forewarned is to be forearmed.”

Superiority of the NORA

In the authors view, The NORA represents an significant, watershed-level of improvement to existing opioid risk assessments for the following reasons: there are numerous opioid risk assessments (ORA) on the market today which are often “quick and dirty” self-report rating scales, are inexpensive to administer and score and provide a nominal scale rating of ‘risk’ as an amorphous construct (i.e., NOT, necessarily, of specific ‘psychobiosocial risk’ factors) based upon the number of item-endorsements a patient makes to the, respective, ORA.

The NORA assesses in the patient many of their major life-domain foci in an effort to assess exclusionary and cautionary psychobiosocial risk factors which may deleteriously impact or, alternatively, enhance consideration for opioid therapy, titration or withdrawal.

Additionally, the NORA recognizes the criticality of the healthcare professional rendering a DSM-5-(or subsequent DSM) based diagnosis of an Opioid Use Disorder, if applicable and, if so, the assertion, via due-diligence-informed clinical judgement, of suspected probable risk as both expressed and implied by the NORA Diagnostic Interview (which presages the NORA DSM-5-Based Criteria).

Also, the NORA recognizes the necessity of incorporating a multi-disciplinary consideration of and contribution to an assessment of ‘risk’ and facilitates coordination and communication of ‘next steps’ in both the Recommended Concurrent Services section, as well as, the Assessor Summary Report section of the NORA protocol.

The NORA protocol has been designed to be a rich, organic and comprehensive methodological approach to an assessment of specific ‘psychobiosocial risk’ factors associated with opioid therapy and culminates in a determination of whether or not a given patient meets the DSM-5 criteria (or subsequent DSM-based criteria) for an Opioid Use Disorder.

Finally, the caveat that ‘clinical judgement’ must be responsibly and accountably applied allows for an Assessor to make an occasional counter-logical recommendation why a patient, who may report some psychobiosocial risk, and may even qualify for a diagnosis for an Opioid Use Disorder, ought to be recommended for consideration of opioid therapy, prescription, titration or withdrawal based upon a multiplicity of potential mitigating considerations in the patient’s NORA assessment along with concomitant recommendations for further consideration offered by the examining clinician.

Our Competition

Existing opioid risk assessments are, essentially, either cursory nominal or ordinal rating scales which provide a number/integer or nominal descriptor to alert the end-user of presumed patient risk, whereas, the NICA OPIOID RISK ASSESSMENT provides the end-user, in real-time, with the careful due-diligence of an competent Assessor identifying, via a structured face-to-face clinical interview, specific psychobiosocial patient risk factors associated with opioid therapy along with whether or not a patient specifically meets the APA’s DSM-5 (or subsequent DSM-based) criteria for a diagnosis of Opioid Use Disorder consonant with appropriate ‘clinical judgement’.

What Differentiates the NORA from All-Others?

The salient differentiating features of the NORA from all-others are the careful due-diligence of an Assessor identifying, via a structured face-to-face clinical interview, specific psychobiosocial patient risk factors associated with opioid therapy along with whether or not a patient specifically meets the APA’s DSM-5 (or subsequent DSM-based) criteria for a diagnosis of Opioid Use Disorder consonant with appropriate ‘clinical judgement’ coupled with specific risk-mitigation suggestions to the prescriber (or referral entity), where appropriate..

The Criticality of Clinical Judgement

In the spirit of professional responsibility and accountability, it is extremely important to recognize that healthcare information obtained from patient’s self-report may be subject to multiple respondent errors resulting from simple “honest mistakes”, to their not fully comprehending a particular question being asked of them, to variable accuracies in the patient’s memory, to selective (conscious or unconscious) recall, to outright fabrication and intentional manipulation.

The astute clinician (or diagnostician) must endeavor to systematically engage in professionally responsible and accountable due-diligence, within their ‘scope of practice’ to elicit meaningful, useful and relevant patient-data, in service of rendering one or more clinical judgements about what the results derived from the assessment actually mean, specific to a given patient.

To this end, the construct, as well as, the actionability of ‘clinical judgement’ requires careful, thoughtful and respectful consideration of as many factors about the patient, about all (similar vs. dissimilar) classes of patients in the clinician’s experience, and about what each assessment-question and corresponding item-endorsement by the patient actually means for and/or represents about that particular patient.

Consequently, ‘clinical judgement’ is required for the examiner to procure reliable and valid data/information from which the clinician can, thereafter, make educated and informed assessments with which to specify dispositional planning (i.e., next steps) for a given patient going forward.

Clearly, not all clinical judgements are equal, nor do they need to be.

However, depending upon the unique interaction effects of a clinician’s education, training, supervision, experience and personal/professional maturity, each clinician ought to be in a tenable position to render an informed assessment of a given patient predicated upon a defensible and verifiable foundation of clinical inquiry from which other healthcare professionals may be in general agreement with recourse to the data-base obtained by the examining clinician.

“Clinical judgement’ is key to this process!

The judicious utilization of good (or appropriate) “clinical judgement,” which is predicated upon the NORA, likely elevates the NORA from merely being a simplistic patient-recitation-documentation of “yes” or “no” (i.e., “1’s” and “0’s” in binary code) responses to a series of clinically interesting questions or inquiries to a “deep-dive” into the patient’s assessed risks associated with opioid use, etc.

And, when the DSM-5 portion (second part) of the NORA is combined with the first part of the NORA, good (or appropriate) “clinical judgement” is still required to “make sense,” not only of the NORA-identified psychobiosocial risk factors and presence/absence of DSM-5-based OUD diagnosis, but also, why or why not opioid therapy ought/ought not proceed based upon the evaluative rationale directly linked to the psychobiosocial risk factors and diagnostic considerations intrinsic to the NORA.

As we consider “clinical judgement” we are respectful of both the quantitative, as well as, the qualitative aspects and ‘value’ of each of these methodological approaches to the dual implicit rhetorical questions: how does one know what one purports to know and what exactly does that mean.

In considering the issues associated with “clinical judgement” one is immediately challenged by the dual implicit philosophical questions, aforementioned in the inquiry.

For example, how does one know that a patient is, or may become, adversely affected by manifest and/or latent psychobiosocial risk factors associated with opioid therapy, especially, if they report ANY significant history of rule-deviance?

If the patient presents, with clinical evidence as suggested by the NORA, as someone who may not be a particularly rule-governed individual and the Assessor stopped further inquiry there, we might not learn that the reported rule-breach may have been a willful act of civil disobedience and, therefore, very possibly the context within which the rule-deviance occurred might give an Assessor pause to reverse an initial negative impression of a quantitative ‘measure’ (i.e., rule-breaker: “yes” = 1; “no” = 0) as a function of a subsequent positive evaluation of a qualitative contextualization of the quantitative datum!

Consequently, by simply quantifying data, in isolation of the context within which that datum results and obtains, and as associated with a given patient, we risk, reducing to the absurd, the clinical value of understanding something truly meaningful about discrete, patient risk factors, and not in a vacuum, but rather, within the existential-phenomenological life-space of the individual patient, by the NORA.

“Clinical judgement” as a hypothetical construct, is both theoretically and practically embedded within the construction of the NORA, and recognizes the considerable potential value accrued to a given patient with respect to the occasional counter-logical and/or counter-intuitive evaluative conclusion a competent Assessor might arrive at if ‘context’ mitigates (psychobiosocial) ‘risk.’

To reiterate the point differently, sometimes (the) reality (of a datum, e.g., risk or risk factors) may be defined or validated insofar as “seeing is believing” and at other times, validated insofar as “believing is seeing.”

Clinical judgement, if professionally adequate, may be just enough for an Assessor to technically “get it right’’ (regarding an assessment of risk, diagnosis, treatment recommendations, etc.), however, if also professionally mature, may be just enough for an Assessor to humanistically “get it right.”

Herein, resides one important distinction between the “technical” aspect of something (e.g., true of false, “yes” or “no,” “1” or “0”) vs. the “art-science-practice” of something which reminds the artful-scientist-practitioner to “never mistake a patient for their symptom" (or their identified psychobiosocial risk factors)!

To be sure, one could certainly flow-chart a decision-tree in accordance with a given rubric or algorithm and, yet, at what point is a competent Assessor only to be informed by the ‘figure’ bereft of the ‘ground’ within which and out from which the ‘figure’ (i.e., patient) emerges and evolves?

Consider a patient, who is a septuagenarian, with a medical diagnosis of malignant brain disease, who requires a life-saving surgery at a cost of $1,000,000 and, who presents with multiple and serious highly debilitating psychobiosocial risk factors.

Pretend that all assessed quantitative measures provide a very poor prognosis for surgery. Pretend, also, that there are one, or more, necessary and/or sufficient qualitative considerations to warrant proceeding with the life-saving surgery, albeit, for this particular patient. This is an example of one crucial challenge with regard to “clinical judgement!”

If the elderly patient is deemed to be “the smartest person in the world” and is weeks away from achieving world peace or completing “the theory of everything” then it may well be in the interests of the patient and the greater universe he/she/they live long-enough to proceed with the medical procedure.

However, if the elderly patient has a demonstrated history of frequent rule-deviance, medication non-compliance and a chronic drug abuse, one may need to work extremely hard to justify the value of why such a given individual should be afforded a life-saving surgery given the limits of one’s resources.

In short, “clinical judgement” further implicates and explicates the Assessor’s professional values, given the prevailing community standards and ethical aspirations of what constitutes acceptable care, with the caveat, as a continuing moderator variable, that “it all depends” on a case-by-case, basis, thus, necessitating more-than-a-modicum of good (or appropriate) “clinical judgement.”

Additional Considerations

The NORA provides a comprehensive, structured, face-to-face, healthcare assessment methodology for identifying relevant exclusionary and/or cautionary (as per duly-authorized and duly-licensed clinical judgement) psychobiosocial risk factors in a given individual, for whom opioid prescription is being considered, titrated, withdrawn, etc., and also the concomitant determination of whether or not that individual meets the APA’s DSM-5-based (or subsequent DSM) criteria for a diagnosis of an Opioid Use Disorder, with a final page for an Assessor’s, albeit, optional narrative Summary Report---the sum total of which provides a healthcare-due-diligence foundation upon which a NORA Assessor can make an informed recommendation to a Prescriber (or other entity) as to the whether or not the individual is a candidate for opioid prescription, etc.

The NORA Diagnostic Interview incorporates additional elements of relevant personal information that are unconventional in aggregation and/or combination for a traditional healthcare clinical interview insofar as inquiries are also made about non-healthcare areas of functioning, the self-reports of which can, potentially, be independently verified with a factual determination by other than the patient-respondent, if so desired.

The NORA methodology goes well-beyond the typical, tightly-focused and what is generally understood to be “here-and-now” healthcare diagnostic interview queries to incorporate a much broader, richer, conventional and unconventional, plus significant extra-solution, clinically relevant, lifestyle “there-and-then” healthcare diagnostic data-gathering information and subject matter which can be utilized by both a qualified Assessor and opioid Prescriber to assess meaningful patterns associated with how a given person is likely to comport themselves (i.e., “yesterday, today, tomorrow”), collaborate and function with respect to ‘psychobiosocial risk’ both within and/or without the context of rules-governed “usual and customary” normative psychobiosocial expectations throughout the entire course of their life.

NORA Validity Considerations

Consistent with its creation, purpose, and clinical value, the NORA arguably enjoys high qualitative construct validity. Currently, the NORA does not (yet) have quantitatively established construct validity.

Criterion validity is not, as yet, established because there are no comparable assessments of this nature against which to evaluate the NORA.

Likewise, content validity has not yet been established, i.e., practical use by healthcare professionals.

The NORA does enjoy demonstrable face validity, i.e., it does what it appears to do.

The NORA authors may consider procuring a research grant to empirically establish, both quantitative-derived construct validity and content validity.

The NORA can effectively serve diverse populations; that is, this instrument enjoys a high degree of generalizability.

Population validity is readily demonstrated by the NORA's applicability to a wide range of affected target populations.

Ecological validity is demonstrated by its applicability across multiple psychobiosocial settings and environments.

Temporal validity is evidenced by its broad-brush, immediate-yet-enduring approach to assessing historical, current, and potential risk.

Outcome validity is evidenced by the findings from a NORA assessment serving to inform Opioid Prescribers across a range of vital psychobiosocial factors.

In short, diligent and vigilant use of the NORA makes it an implementable, universal clinical tool.

Perhaps NORA will be at its best if and when its convergent validity and its predictive validity, respectively, can be established, qualitatively and/or quantitatively.

Summary of Relevant Literature

According to the New England of Medicine (https://catalyst.nejm.org/doi/full/10.1056/CAT.18.0197):

“Risk management in healthcare comprises the clinical and administrative systems, processes, and reports employed to detect, monitor, assess, mitigate, and prevent risks. By employing risk management, healthcare organizations proactively and systematically safeguard patient safety as well as the organization’s assets, market share, accreditation, reimbursement levels, brand value, and community standing.”

Additionally, “The healthcare risk management plan needs to be a living document that is frequently updated and improved based on emerging risks, lessons learned, new information, and changes in the healthcare system and practice of medicine. The plan should have provisions for communication and training when these updates and changes are made.”

Comment: The NORA is intended to be “a living (i.e., “organic”) document” that identifies, a priori, clinically relevant psychobiosocial patient-risks associated with careful medical consideration of opioid pain medication in service of addressing, mitigating or eliminating said risks in a given patient subsequent to “employing risk management… (to) proactively and systematically safeguard patient safety as well as the organization’s assets…”

According to the National Institute of Health (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5923681/):

“Clinical risk includes any undesirable situation or operational factor that may have negative consequences for patient safety or capable of causing an adverse event (AE). The AE, intentional or unintentionally, may be related to the human factor, that is, medical errors (MEs). Therefore, the importance of the health-care risk management is a current and relevant issue on the agenda of many public and private institutions. The objective of the management has been evolving from the identification of AE to the assessment of cost-effective and efficient measures that improve the quality control through monitoring.”

Also, “Only the recognition of the causes of the AEs allows adopting effective strategies to reduce them.”

Comment: The NORA endeavors to reduce intentional or unintentional adverse events and medical errors by systematically investigating the self-report responses of a given patient by direct, face-to-face inquiry with a duly-licensed healthcare assessor with the option of corroborating self-report information with external data (e.g., toxicology report, medical, psychological, legal, military, employment, marital, financial records, etc.).

According to the BBC Academy (https://www.bbc.com/academy-guides/how-to-do-risk-assessment):

“Risk assessment is a simple way to plan what you're going to do to minimise the chances of anybody getting hurt or causing damage to property or equipment. It's how to identify sensible measures to control the risks in your workplace.”

Also, “The risk assessment process is simple.

You should:

identify what could go wrong
identify who might be affected and how they might be harmed
identify controls that are needed to stop it going wrong
show that any remaining risk after all reasonable controls are in place is low enough to be acceptable
record all of your findings and keep it
tell everyone what they need to know and do
make sure it all gets done
ensure that if anything changes, you check you’ve got the right things in place. If not, stop the activity and review what's needed.”

Comment: The NORA incorporates the spirit of the aforementioned risk assessment process into the aggregate assessment with the avowed goal “…to minimise the chances of anybody getting hurt or causing damage to property or equipment. It's how to identify sensible measures to control the risks…”

According to the American Society of Safety Professionals

“RISK IDENTIFICATION:

To effectively address the hazards and risks within a workplace, you must first properly identify them. When conducting risk identification, the ISO 31000-2018 standard recommends that safety professionals and stakeholders examine a wide variety of factors, including:

-Tangible and intangible sources of risk

-Threats and opportunities

-Causes and events

-Consequences and their impact on objectives

-Limitations of knowledge and reliability of information

-Vulnerabilities and capabilities

-Changes in external and internal context

-Indicators of emerging risks

-Time-related factors

-Biases, assumptions and beliefs of those involved

RISK ANALYSIS:

Working from the information gathered during risk identification, stakeholders can then begin to analyze the risk levels of certain hazards and prioritize actions based on existing controls, among other criteria. Risk analysis involves a detailed consideration of uncertainties, hazards, consequences, likelihood, events, scenarios, controls and their effectiveness. An event can have multiple causes and consequences and can affect multiple objectives.

RISK EVALUATION:

As the final step of risk assessment, risk evaluation calls on safety professionals to examine the results of the risk analysis and compare them to established risk criteria in order to determine where additional controls may be required and what those controls might be.

RISK COMMUNICATION:

Threaded throughout all steps of the risk assessment process is a fourth element, equally crucial to effective risk management – risk communication. Safety professionals must keep in mind that they must communicate the risks identified, analyzed and evaluated during the assessment to all involved so that everyone has a comprehensive understanding of the existing risks and how they can best be prevented or mitigated to achieve organizational objectives.”

Comment: The NORA is a systematic, stand-alone, healthcare protocol which rapidly identifies risk, analyzes risk, evaluates risk and communicates risk in a clinically-relevant, clinically-meaningful and clinically-proactive manner.

To be sure, one source of potential bias is inherent in the patient’s self-report narratives or in their item-endorsements, however, the NORA does allow for additional sources of psychobiosocial corroborating information, external collateral reports, healthcare and/or other pertinent records, as well as, additional formal psychological and/or medical testing, if it is deemed to be clinically indicated.

Furthermore, the construct of ‘risk’ conveys immediate and suspected or probable danger. Consequently, the NORA provides an Assessor with the latitude to address both general and specific ‘psychobiosocial risk’ factors, along with proposed concomitant risk-mitigation suggestions, in the optional Summary Report (p 25) following completion of the requisite due-diligence required for the entire NORA administration (pp1-24).

According to the European Patients’ Academy

(https://toolbox.eupati.eu/resources/risk-factors-in-health-and-disease/):

“Health and wellbeing are affected by many factors – those linked to poor health, disability, disease or death, are known as risk factors. A risk factor is a characteristic, condition, or behaviour that increases the likelihood of getting a disease or injury. Risk factors are often presented individually, however in practice they do not occur alone. They often coexist and interact with one another.”

Also, “There is a rising demand for healthcare, placing the sector under increasing budget pressure which is not always met. It is important that we, as a society and users of healthcare systems, understand the causes and risk factors behind diseases, so that we can actively take part in available cost-effective prevention and treatment programmes.

In general, risk factors can be categorised into the following groups:

Behavioural
Physiological
Demographic
Environmental
Genetic

Reducing contact (exposure) to risk factors would greatly improve global health and life expectancy by many years. This would therefore reduce healthcare costs.”

Comment: The NORA is, essentially, a comprehensive psychobiosocial risk protocol which implicates geopoiliticoeconomic and other (e.g., religious, moral, legal, marital, military, occupational, etc.) risk factors and is the only extant opioid risk assessment instrument to do so with respect to opioid prescription, titration or withdrawal. Although initially designed as a qualitative “clinical” assessment instrument, the NORA does recognize the contribution of quantitative assessment information which can be incorporated and/or appended to the NORA at any time before and/or after the NORA has been administered. Additionally, it is important to note that built into the design of this assessment protocol, the NICA OPIOID USE DISORDERS RISK ASSESSMENT: DSM-5-BASED CRITERIA portion of the NORA has been derived from the Diagnostic and Statistical Manual of the American Psychiatric Association which both expresses, as well as, implies a “statistical” (i.e., quantitative) function served by the NORA.

According to the National Institute of Health (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2639900/):

“Medical errors represent a serious public health problem and pose a threat to patient safety. All patients are potentially vulnerable, therefore medical errors are costly from a human, economic, and social viewpoint.”

Also, “Errors in medicine have to be seen as a dimension of quality of care and organizational performance. An effective response to harm must be based on a reliable risk management policy aimed at minimizing the chances of recurrence of an avoidable medical error.”

Comment: The NORA is purposed to systematically and rapidly investigate and identify specific psychobiosocial risk factors which might pose a potential for harm an identified patient for whom opioid therapy is being considered in order to address and ameliorate untoward or avoidable risk to the patient, as well as, medical error endemic to the prescriber.

Finally, “Reduction of medical error and harm can be put in the broader context of safety and quality of care by providing a framework to assess and evaluate the structure, process and outcomes of care. Healthcare is characterized by a reliance on human operators who work with increasingly complex technology and variable levels of uncertainty. This can lead to error and needs to be managed through a framework where organizations are available for continuously improving the quality of services and safeguarding high standards of care.

A systematic approach to patient safety should be adopted where responsibility for safety is shared by all members of the healthcare teams. In fact, significant errors occur in all phases of patient care. There is no single area where change will eliminate error. Likewise, a multitude of individuals and services are involved in errors. Although training physicians (or any other single profession) about errors should be beneficial, major strides in safety will likely require educating all those involved in patient care.

Efforts to reduce errors should be proportional to their impact on outcome (preventable morbidity, mortality, and patient satisfaction) and the cost of preventing them.”

Comment: The NORA represents a multi-disciplinary, modus operandi, to responsibly and systematically assess psychobiosocial risk, to make recommendations to the referring entity to, hopefully, decrease reducible risk and to communicate to key stakeholders meaningful, useful and relevant information about the identified patient which may have significance for a more comprehensive assessment and understanding the role any assessed ‘risk’ represents to the identified patient…and to their prescription prescribers, etc.

According to the National Institute of Health (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582547/):

“A scientific understanding of clinical risk management (CRM) in mental health care is essential for building safer health systems and for improving patient safety. While evidence on patient safety and CRM in physical health care has increased, there is limited research on these issues in mental health care.”

Comment: The NORA specifically incorporates systematic inquiry about mental health issues and concerns in some detail to extend traditional CRM in medical health care and permits individualized elaboration by the patient, as needed.

Also, “Understanding and improving patient safety is a growing concern, particularly following the publication of the Institute of Medicine reports “To err is human”, “Crossing the quality chasm” and the NHS’s “Organisation with a memory”. These reports highlight that between 3.7-16.6% of patients admitted to hospitals suffer an adverse event, at least half of which are preventable. Such adverse events can result in unnecessary injury or death as well as enormous economic costs. Despite being ostensibly concerned with patient safety and minimizing risks in health care, a systematic approach to patient safety or a systematic organizational management of clinical risks is difficult to implement and therefore, seldom seen.

Nevertheless, research and knowledge on patient safety, have increased rapidly and improved many aspects in acute medical health care settings. However, in mental health care, there is a “lack of awareness of the issues as well as a shortage of research and information on the topic”, p. 39]. A comprehensive literature review highlights an inconsistency in basic patient safety concepts in mental health (e.g., defining and calculating adverse events), as well as a scarcity of high-quality patient safety research in mental health. Due to the resulting lack of patient safety principles specific to mental health care, concepts and strategies from acute medical health care settings are frequently adopted. This may be appropriate for some aspects, but mental health care differs from medical patient care in patient population and illnesses, as well as in historical and institutional contexts. There are also unique patient safety issues in mental health care that require further consideration, especially with regard to clinical risks. While medication related risks, such as medication mix-up or delivery of wrong dose, are found in acute medical care and mental health [e.g., specific risks, such as suicide, violence and self-harm prevail in mental health. To date, an overview of the spectrum of clinical risks found in mental health and the organizational risk management practices currently applied is lacking. Furthermore, a systematic clinical risk management (CRM) can play a crucial role in enabling health care organizations to assess, manage, and contain risks related to patient safety and aims at reducing or eliminating harm to patients.”

Comment: Clearly, the NORA serves to provide for “a systematic clinical risk management (CRM) (which) can play a crucial role in enabling health care (providers and) organizations to assess, manage, and contain risks related to patient safety and aims at reducing or eliminating harm to patients.”

Also, “The current study adds to the understanding of patient safety and raises awareness for clinical risks in mental health. It uses expert interviews as an empirically sound way of generating knowledge in an emerging field that suffers from a shortage of research activity and empirical evidence. The overview of the main risk themes of CRM in mental health care and the proposed organizational CRM practices offer a valuable basis for CRM in psychiatry and an addition to CRM in hospitals in general. Psychiatric hospitals can use the overview to review the completeness of their assessment and knowledge of risks. It can also be used to prioritize the risks that need to be addressed. The CRM practices mentioned in the interviews provide guidance on how to deal with these risks.”

Comment: The NORA, as a structured, face-to-face, ‘expert’ clinical interview serves “as an empirically sound way of generating knowledge in an emerging field that suffers from a shortage of research activity and empirical evidence.” [N.B. Empirical knowledge may be derived either nomothetically and/or ideographically. As such, the ‘data’ that are obtained may be either quantitative and/or qualitative. The NORA protocol is one systematic and comprehensive procedural methodology which facilitates the acquisition of said empirical knowledge, yet, respects the Assessor’s national, regional or local community standard(s) of care in the requisite ‘clinical judgements’ needed to make sense of the empirical knowledge, to interpret the ‘data’ and to render both a DSM-5 (or subsequent DSM-based) diagnosis of an Opioid Use Disorder and/or make recommendations regarding further disposition specific to risk-mitigation.

According to the National Institute of Health (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699803/):

“Opioid use disorder risk assessment tools cannot be used in isolation. In combination with standardized clinical examination, and, when indicated, urine drug screening, a validated risk assessment tool, improves the ability to detect opioid misuse. Even though no single tool has been shown to have both high interobserver reliability and high sensitivity, the standardized approach has still been shown to be superior to subjective care giver assessment.”

Comment: The NORA is a sequential, multi-modal, multi-disciplinary risk assessment tool which is NOT intended to be utilized in isolation of other pertinent sources of information. Additionally, its clinical reliability, clinical validity, and clinical and psychobiosocial-geopoliticoeconomic utility may be further enhanced by incorporating available psychobiosocial patient data (i.e., healthcare records and collateral-source information) along with the option of augmenting the NORA, at any time, with formal psychological and/or medical and/or other relevant psychobiosocial assessment and/or tests deemed to be clinically necessary by the NORA Assessor and/or the referral entity.

“Assessment requires the care giver use a standardized systematic approach to all patients who will be receiving (or are at risk of misusing) opioids.”

The NORA protocol has been, especially, structured to apply a ‘standardized’ systematic approach to all referred patients who will be receiving (or are at risk of misusing) opioids.

Please note that the term ‘standardized’ reflects the aspirational ‘standard’ of utilizing a systematic approach in a, generally, standard manner in rendering the NORA’s psychobiosocial risk assessment and DSM-5-based criteria for an OUD but with all due consideration for the ‘organic nature’ of systematic clinical inquiry which, sometimes, necessitates some clinically-judicious deviation from the “cookie-cutter” formulaic approach of a simplistic assessment tool.

“Although this essay’s focus is on the use of risk assessment tools, these tools cannot be used in isolation. The assessment of a patient presenting with either acute or chronic pain involves several distinct steps:

Biological assessment: history and physical examination should be performed to assess the anatomical and pathophysiologic sources of pain as well as previous diagnoses and treatment modalities for similar or other pain episodes. The pain intensity, pattern, quality and location are essential elements of this initial step. All of these descriptors aid in correctly diagnosing the type of pain a patient suffers and the types of analgesics that would be optimal. For many types of chronic pain, including neuropathic and diffuse wide spread pain, opioids offer little or no benefit.
Social assessment: home and work circumstances, social functioning, and any possible disability or impairment resulting from or related to pain
Psychological Assessment: It is important to assess patient’s coping skills, any ADRB (aberrant drug related behavior), SUD (substance use disorder), addiction risk and history. The focus on addiction risk assessment and ongoing risk mitigation is outlined in the following sections.”

Comment: The NORA permits a structured clinical investigation of biological, social and psychological assessments, per above, all “under one tent” within the NORA assessment protocol and also via its optional testing, documentation and collateral-informant pathways, in the event further clinical information is requested or required.

Also, “Many studies have examined the prevalence of SUD and non-medicinal opioid use in specific populations, including those suffering from chronic pain. Important risks to patients who are prescribed opioids for pain include death, overdose and the development of an OUD (opioid use disorder). Given the enormous burden of opioid addiction, chronic non-cancer pain guidelines strongly suggest screening all patients for risk of substance abuse, misuse, and addiction before prescribing opioids. Quantifying that risk can be challenging.”

Comment: The NORA is an example of a comprehensive assessment protocol which, not only, screens for an Opioid Use Disorder but, also provides for a diagnosis of an Opioid Use Disorder, if applicable Furthermore, even if a patient may be suspected to be or actually is ‘at-risk’ for an Opioid Use Disorder, an astute Assessor may apply the due-diligence of the NORA obtained results to make recommendations for consideration by a prescriber (or referral entity) as to the mitigating rationale for consideration and/or continuation of opioid prescription, even in those instances where a patient is not in a chronic cancer or end-of-life status.

“Multiple risk assessment tools were developed in an attempt to help quantify and identify patients more likely to suffer from SUD. These often rely on self-reporting and are thus dependent on patients answering questions honestly: misrepresentation of their past histories or behaviors may significantly impact the resulting risk score. While the possibility of dishonesty may make us skeptical of answers, it should not preclude using these tools. Variability in the patient populations included in derivation studies as well as in some of the outcomes measured also weaken the ability to generalize the value of these tools. As a result, there is no one risk assessment tool that can guarantee accurate risk for any one patient. Until we incorporate DNA testing in our routine clinical care, the only way to prevent the development of an OUD is to keep a patient opioid-naïve, a solution that for many is neither practical nor optimal care. Ongoing prescribing of an opioid should be made understanding the limitations of the risk assessment tools, following the patient appropriately, and screening for ADRB on a regular basis. The performance of these tools in specific clinical environments (e.g., emergency department, hospital ward, pain clinic) has not been sufficiently studied for a specific tool to be recommended for a specific environment. Despite these limitations, it has been shown that use of a standardized tool is superior to practitioner subjective impressions; the latter is not recommended for risk assessment. The extra time to do a standardized risk assessment is well worth it, not only by reducing stress but also by providing better patient outcomes.”

Comment: The NORA is a systematic clinical assessment tool which incorporates “multiple risk assessment tools”, per above, into its design and administration. While it is a primarily a qualitative instrument, it does permit, secondarily, several quantitative options.

Although the NORA relies heavily upon self-report data, such data ought not, ipso facto, be minimized or summarily discounted because not all patient-informants are unreliable or deceitful.

Even those who may have a demonstrable Opioid Use Disorder (or other substance use disorder) may still benefit from structured opioid therapy if the relevant psychobiosocial risk factors can be responsibly addressed and/or appreciably mitigated such that benefit from opioid prescription can appropriately outweigh risk.

Furthermore, additional sources of corroborating and/or collateral information, inclusive of formal psychological and/or medical and/or other relevant tests make the NORA an extremely utilitarian, heuristic and immediately applicable assessment instrument.

Finally, per above, “Despite these limitations, it has been shown that use of a standardized tool is superior to practitioner subjective impressions; the latter is not recommended for risk assessment. The extra time to do a standardized risk assessment is well worth it, not only by reducing stress but also by providing better patient outcomes.”

Comment: The NORA is such a recommended tool!

Extant Opioid Risk Assessment Tools

The table, below, from the above referenced NIH citation, identifies 16 different opioid risk assessment tools:

Tool	Validated (y/n)	Year of publication
Aberrant Drug Behavior Index	N	2007
Addiction Behaviors Checklist	Y	2006
Brief Risk Interview	Y	2013
Brief Risk Questionnaire	Y	2015
Current Opioid Misuse Measure	Y	2007
Diagnosis Intractability Risk and Efficacy Score	Y	2006
Drug Misuse Index	N	2007
Opioid Compliance Checklist	N	2014
Opioid Risk Tool	Y	2005
Patient Medication Questionnaire	Y	2004
Prescription Drug Use Questionnaire	N	1998
Prescription Drug Use Questionnaire Self-Report	Y	2008
Prescription Opioid Misuse Index	N	2008
Prescription Opioid Therapy Questionnaire	N	2004
Screener and Opioid Assessment for Patients with Pain-Revised	Y	2008
Screening Instrument for Substance Abuse Potential

“To reach the point where a risk assessment tool can be highly reliable for the patient in front of you will be extremely difficult – it is why the use of the available tools must be combined with other factors as we have indicated. How do researchers overcome possible dishonesty of patients, something almost never seen in other types of clinical research? We would need to identify and demonstrate reproducibility of test results, interobserver reliability and consistency of results in different clinical settings. It is easy for the clinician to be skeptical of these tools and continue to rely on subjective impressions; nevertheless, such an approach, as stated above, may lead to worse outcomes for the patient.”

Comment: The NORA is NOT designed to be a simplistic, “quick and dirty”, screening instrument to ‘catch’ a possibly dishonest patient. Rather, the NORA is a comprehensive, labor-intensive, systematic, face-to-face, investigative clinical study of exclusionary and cautionary psychobiosocial risk factors, per the ‘clinical judgement’ of an authorized healthcare Assessor, coupled with a concomitant duly-licensed assessment of the patient for DSM-5 (or subsequent DSM) based criteria evaluation for a diagnosis (or not) of an Opioid Use Disorder, with the added expectation for each Assessor to make specific, relevant, individualized and implementable recommendations for consideration, by a prescriber (or other referral entity), to address and/or mitigate suspected, probable or actual psychobiosocial risk associated with administration of opioid prescription, titration or withdrawal.

“Healthcare providers who treat chronic pain should be familiar with urine drug monitoring as risk assessment is greatly enhanced by properly employing and interpreting these tests. In fact, it is one of the few objective measures available that can provide valuable information often not forthcoming when implementing other comprehensive strategies for risk mitigation.”

Comment: The NORA specifically provides for pre/concurrent/post option(s) to procure toxicology screening reports or other appropriate laboratory testing within the last 12-36 hours.

The authors of the citation (#31.), above, caution that:

“Clinicians need to understand test characteristics including the possibilities for false positive and false negative results before ordering or attempting to interpret urine drug tests. Communicating with the lab facility may allow clarification of the limitations and proper interpretation of results; consultation with the lab you will use should be sought out before employing urine drug testing with patients. The tests should include a package insert which explains their limitations, i.e., what will turn the test positive. Not understanding this leads to poor patient care. For instance, patients have been fired after receiving a prescription for oxycodone and having a negative opioid screen as the provider did not realize the assay did not detect oxycodone.”

Comment: The NORA provides ‘space’ for an Assessor to obtain primary-source, self-report, opioid-use information from a given patient and allows for a given patient to offer to the Assessor their understanding of why, or why not, a particular substance may be detected from a toxicology screen.

For example, it is possible that an individual, who tests positive, may have been unconscious during hospital treatment for a serious injury and may have been prescribed opioids, which would then be expected to show-up in a toxicology screen, but not, necessarily, with the patient’s awareness that he/she/they had been administered opioid therapy.

When such a patient is confronted with their assertion upon direct examiner inquiry that they do not use opioids but a toxicology-screen states otherwise, the patient can communicate their understanding of the discrepancy in obtained results, from the patient’s perspective.

The Assessor then ‘assesses’ the plausibility of the patient’s denial within the larger context of the NORA protocol, in toto, along with any other pertinent data.

One enormous advantage of an Assessor discussing toxicology screening results, if available, with the referred patient is for the Assessor to consider the possible influence of either false positive or false negative obtained results.

Again, according to the authors referenced in the above citation:

Comment: Consequently, in this vein, one important goal of the NORA is to consider multiple sources of meaningful, useful and relevant information, inclusive of the patient’s representations, to facilitate a competent healthcare Assessor to systematically think, judge and act upon the information procured, through the due-diligence of a comprehensive psychobiosocial risk assessment and DSM-5 (or subsequent DSM) based criteria for the determination of an opioid use disorder.

It bears reiterating that even if a patient meets multiple ‘risk factors’ AND meets the DSM-5-based criteria for an Opioid Use Disorder, it is the professional bias of the NORA authors, that so long as there are appropriate recommendations and necessary healthcare (and other life-domain) services available to address and/or mitigate untoward risk, then responsible clinical judgement may prevail in a prescriber’s determination whether or not to prescribe, titrate or withdraw opioid therapy.

“There is poor evidence for the effectiveness of opioid treatment agreements, but they may help clarify a “universal precautions” approach. Furthermore, a written agreement may clarify the goals of opioid trials, tapers, and also when it may be reasonable to terminate opioid therapy. The authors recommend using treatment agreements for use of opioids for chronic non-cancer pain.”

Comment: The NORA specifically makes provision for discussing with the patient their readiness, willingness and ability to commit to a narcotic pain medication usage agreement on the condition that repeated violations of use may result in the discontinuance of the prescribed medication(s).

“None of the risk assessment tools are able to predict perfectly which patients will ultimately suffer from OUD if prescribed opioids in their pain management.”

Also, “Despite relatively weak evidence to support the use of any one tool, recommendations strongly encourage use of risk assessment tools prior to initiating opioid therapy. Risk assessment should be repeated regularly during the course of opioid therapy. To optimize a combination of universal precautions and risk assessment prior to prescribing, clinicians should also make use of urine drug screening to provide the most consistent approach for opioid risk assessment. Risk assessment tools and urine drug screening both have flaws, but using them provides better patient outcomes than physician subjective impressions.”

Conclusion

The NORA is an assessment of wide-ranging utility, not only of assessing opioid use (or other substance use) risk and not only of assessing adverse drug related behaviors, but also of assessing a multitude of psychobiosocial risk factors which, a priori and a posteriori, appear to be clinically implicated in both opioid risk, broadly construed, and Opioid Use Disorder, more specifically.

Since the NORA is not primarily designed solely to be a statistical tool, per se, it does not seek to make statistical risk-predictions (excepting for the, respective, DSM-5-Based Criteria portion of the protocol).

However, the NORA certainly serves as a serious interactive methodology, to investigate and identify suspected, probable or actual psychobiosocial risk-factors, to summarily result in a clinical judgement, predicated upon the due-diligence required by the NORA administration, culminating in making specific recommendations for consideration by the prescriber (or other referral entity) for opioid therapy, or not, along with suggested risk-mitigating services.

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